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Disinfectants and Sterilants

Overview​

Disinfectants and sterilants used on medical devices are themselves regulated as medical devices in Australia. This is a common point of confusion — the product doing the disinfecting is subject to the same regulatory framework as the device it is used on. If your product is intended to disinfect, sterilise, or decontaminate a medical device, it must generally be included in the ARTG before it can be supplied in Australia.

This page covers disinfectants and sterilants regulated as medical devices. Products used to disinfect surfaces, skin, or the general environment — without a specific intended purpose of disinfecting medical devices — are regulated differently and may fall under other frameworks including medicines or general consumer products.

What Is Regulated as a Medical Device​

Under the classification rules in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002, a disinfectant or sterilant is regulated as a medical device when it is intended by the manufacturer to be used for:

  • Disinfection of a medical device — cleaning and decontaminating instruments, endoscopes, reusable devices, or other medical equipment
  • Sterilisation of a medical device — achieving a sterile state for devices intended to be used in sterile conditions

The product does not need to be complex — a simple chemical solution intended for disinfecting endoscopes is a medical device.

Classification​

Most disinfectants and sterilants for medical devices fall into Class IIa or Class IIb depending on:

  • The intended use (surface disinfection vs. high-level disinfection vs. sterilisation)
  • Whether they are intended for use on critical devices (those entering sterile body cavities — higher risk) or semi-critical devices (those contacting mucous membranes)
  • The level of activity claimed (low-level, intermediate-level, or high-level disinfection, or sterilisation)

General classification guidance:

  • Low or intermediate-level disinfectants for semi-critical device surfaces: typically Class IIa
  • High-level disinfectants and chemical sterilants for critical devices: typically Class IIb

Always refer to Schedule 2 and current TGA classification guidance to confirm the correct class for your specific product.

👉 How Classification Works

Key Regulatory Requirements​

Essential Principles Disinfectants and sterilants must meet the Essential Principles, including:

  • EP 7 (chemical, physical and biological properties) — biocompatibility and material compatibility with the devices to be disinfected
  • EP 8 (infection and microbial contamination) — efficacy claims must be validated
  • EP 13 (labelling) — instructions for use must include dilution, contact time, temperature, and compatibility information

Performance validation Efficacy claims — including the specific organisms the product is effective against, at what concentration, and at what contact time — must be validated by testing. The TGA expects efficacy data to support all claims made in labelling and promotional materials.

Labelling requirements Labels must clearly state:

  • The intended use and applicable device types
  • Instructions for use including dilution ratios and contact times
  • Compatibility with specific device materials (endoscopes, metals, rubber, etc.)
  • Safety precautions and handling instructions
  • Shelf life and storage conditions

Reprocessing Instructions for Reusable Devices​

If you manufacture a reusable medical device, the instructions for use must include validated reprocessing instructions — specifying which disinfectants and sterilants are compatible with the device. This is an Essential Principle 8 and 13 obligation. The disinfectant or sterilant used must have a current ARTG entry covering the applicable device types.

Hospitals and healthcare facilities have obligations under their accreditation frameworks to use disinfectants that are appropriately approved for the devices they reprocess.

Excluded Products​

The following are not regulated as medical devices:

  • Hand sanitisers and skin antiseptics — generally regulated as medicines
  • General surface disinfectants not intended for use on medical devices
  • Hospital-grade disinfectants for environmental surfaces and floors (not for disinfecting devices)
  • Sterile water or saline for irrigation (these may be regulated separately as medicines)

The intended purpose stated in labelling and promotional materials determines regulatory classification — a product claiming to disinfect endoscopes is a medical device even if its active ingredient is also used in non-medical disinfectants.

Official Sources​

Excluded Products

Not all disinfectants and sterilants are regulated as medical devices. Products fall outside the medical device framework when they are intended for:

General surface disinfection — cleaning environmental surfaces, benchtops, or general facility cleaning not specifically intended for medical devices Personal hygiene and skin disinfection — hand sanitisers, skin antiseptics, or products for personal use Household and consumer use — general-purpose disinfectants marketed for home or consumer purposes If a disinfectant product's labelling, marketing, and intended purpose do not specifically reference medical device disinfection or sterilisation, it may fall under the medicines framework (as an antiseptic or disinfectant medicine) or consumer product regulation instead.